BODY CARE GIFT SET- zinc oxide kit

body care gift set by

Drug Labeling and Warnings

body care gift set by is a Otc medication manufactured, distributed, or labeled by giggle. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide: 19%

Purpose

Skin Protectant

Uses

* Helps treat and prevent diaper rash
* Protects chafed skin associated with diaper rash
* Helps protect against wetness

Warnings

For external use only.

When using this product * avoid contact with eyes.

Stop use and ask a doctor if * condition worsens * symptoms last more than 7 days or clear up and return again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

* Change wet or soiled diaper promptly. * Cleanse the diaper area and allow to dry. * Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged.

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil (1), Beeswax (1), Glyceryl Dibehenate, Tribehenin, Aloe Barbadensis Leaf Juice (1), Glyceryl Behenate, Tocopheryl Acetate, Carthamus Tinctorius (Safflower) Seed Oil (1), Olea Europae (Olive) Fruite Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Calendula Officialis Flower Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1)(1) Certified Organic Ingredient

Questions?

Questions? Visit giggle.com or call 800-495-8577

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BODY CARE GIFT SET 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70306-9804

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70306-9804-9	1 in 1 KIT	03/01/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	355 mL
Part 2	1 JAR	85 g
Part 3	1 TUBE	118 mL

Part 1 of 3

FACE AND BODY LOTION 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	CASTOR OIL (UNII: D5340Y2I9G)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	CHAMOMILE (UNII: FGL3685T2X)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	YELLOW WAX (UNII: 2ZA36H0S2V)
INGR	ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
INGR	CARNAUBA WAX (UNII: R12CBM0EIZ)
INGR	HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
color	white	C48325
flavor	VANILLA	C73421

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		355 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		03/01/2016

Part 2 of 3

ALL-PURPOSE WONDER BALM 
other baby products ointment

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	CASTOR OIL (UNII: D5340Y2I9G)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	YELLOW WAX (UNII: 2ZA36H0S2V)
INGR	HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
INGR	ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
color	white	C48325

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		85 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		03/01/2016

Part 3 of 3

DIAPER RASH CREAM 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 70306-1851
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CHAMOMILE (UNII: FGL3685T2X)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
SAFFLOWER OIL (UNII: 65UEH262IS)
OLIVE OIL (UNII: 6UYK2W1W1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TRIBEHENIN (UNII: 8OC9U7TQZ0)

Product Characteristics
Color	white (Off-White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70306-1851-4	118 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2016

Labeler - giggle (194045402)